Central Venous Catheter PlacementNCT05338138
Point of Care Ultrasonography Versus Standard Blind Technique for Central Venous Catheter Insertion in Emergency Hospital
An observational study of Central Venous Catheter Placement, run by Zagazig University at 1 site in Egypt.
Trial summary
A lot of complications occur during central venous catheter insertion in intensive care units all over the world most commonly pneumothorax, misplacement and infection. So in this study we will assess the effect of using ultrasonography guidance for CVC insertion to reduce incidence of complications and to confirm… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Venous Catheter Placement
- What is being tested?
- ultrasound guided central venous catheter insertion
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Oct 2021to 5 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be selected from emergency hospital at zagazig university hospitals who needed CVC insertion as an important part of management plan.
Who may be able to join
- Patient acceptance (if conscious)
- Aged >18years.
- Gender: both.
- 5. Patients admitted to emergency hospital units, at emergency room (ER), operation theater (OT) or emergency intensive care unit (ICU)
Who cannot join
- Patient refusal
- Coagulopathy: INR>1.5 or platelet count<500000/cc
- Skin infection at site of insertion
- Physician not well trained on utilization of ultrasound machine or even not familiar with it.
- History of surgical manipulation or trauma at the insertion site
- Trauma to other structures (e.g. cervical spine collar is a soft contraindication to an IJ central venous catheter (CVC) placement, a pelvic binder is a contraindication to a femoral CVC placement)
Trial locations and contacts
1 site in 1 country.
About this study
A lot of complications occur during central venous catheter insertion in intensive care units all over the world most commonly pneumothorax, misplacement and infection. So in this study we will assess the effect of using ultrasonography guidance for CVC insertion to reduce incidence of complications and to confirm placement compared to standard blind technique.
Read the detailed description
Central venous catheter (CVC) - also called central venous access, central venous line, or central line - is a thin catheter that is inserted through one of the large veins in the neck area into the venous system. It ends in one of the venae cavae just before entering the right atrium.
CVC is a procedure frequently required in critical care units. Indications include patients with multiple, incompatible intravenous (IV) medications with limited peripheral access, or who are being treated with vasoactive or phlebosclerotic agents which may not be suitably cared for with a peripheral IV alone. Some central lines are also placed for temporary or permanent hemodialysis access; these dialysis catheters are significantly larger than traditional double, triple, or quadruple lumen catheters placed in the emergency department or intensive care unit setting.
Central lines are placed today via the Seldinger technique, in which the chosen vein is cannulated with a needle, a guidewire is inserted to maintain a tract through the skin into the vein, and the catheter is then inserted over the wire into the vein before the wire is removed. When this procedure was performed blindly it was called the standard technique, while if it was done with ultrasound guidance it is called ultrasound guided technique.
Patients were selected from emergency hospital at zagazig university hospitals who needed CVC insertion as an important part of management plan
All Cases underwent:
- Patient Examination: regarding written consent from patients or relatives when possible, site of planned insertion, explanation to the patient if conscious and cooperative and checking platelet count and INR if available (not necessary in emergency situation)
- Randomization: A computer-generated randomization table allocated the patients into 2 equal groups.
- Preparation: Once the site was chosen, a topical antiseptic such as chlorhexidine or betadine was applied circularly to the skin in ever-enlarging circles. Once applied, the antiseptic was allowed to dry to maximize the decrease in skin surface bacterial cell count. After securing the line in vivo, it was also common practice to flush the central line with sterile saline to prevent clotting within the catheter, as well as to confirm the functionality of all ports. This step was performed both prior to insertion and after insertion of the catheter.
- Personnel: When possible, having an assistant present during the procedure was helpful.
- Equipment for CVC insertion:
- Central line insertion kit, which is usually manufacturer-specific should contain the all the equipment for the central line and Seldinger technique, including a central venous catheter, guidewire, syringe, an introducer needle, a scalpel, a silk suture (on a Keith or curved needle) and a skin dilator
- Sterile gloves and gown
- Hat and mask
- Drape or sterile towels to create a sterile barrier (to protect equipment and materials from becoming contaminated)
- Antiseptic agent for skin preparation
- Proper caps for each lumen port
- Dressing to cover the insertion site
- Local anesthetic (1% to 2% lidocaine)
- If an ultrasound-guided technique was used, a sterile probe cover was used.
- Technique:
In group A: the insertion site was anesthetized by injecting local anesthetic sufficient to create a wheal under the skin. then the needle was advanced towards the venous target, aspirating then injecting anesthetic into the subcutaneous tissue. Once the area is anesthetized, the introducer needle was introduced into the skin, and advanced toward the vein being cannulated, all the while aspirating with steady pressure. then continued as seldinger maneuver In group B: the ultrasound machine was employed using the linear probe, the probe was covered by a sterile cover, and then localization of internal jugular vein (IJV) was done. The IJV was adjusted to be at the center of the ultrasound monitor view then slight compression on IJV was done to ensure its patency and collapsibility and to differentiate IJV from carotid artery that should be visualized beside or behind the IJV as a pulsating non collapsible vessel that colors red on Doppler while the IJV colors blue on Doppler. then the next steps were continued as the standard blind technique. Immediately after CVC placement, a saline flush consisting of 10 mL of normal saline was injected into the distal hub of the CVC by the interventionist while focused echocardiography was conducted by a second resident. The time required for the procedure was recorded. Appearance of an opacification of the right atrium (RASS) was judged as "immediate" (less than two seconds after injection), "delayed" (appearing more than two seconds after injection) or "absent". Echocardiography was immediately evaluated by the resident placing the catheter and the result ("delayed", "immediate" or "absent" flush) recorded by one investigator (EM). The examination was repeated up to three times and catheter position corrected during placement when the saline flush test was indicative of a problem. Overall, a positive RASS (negative screening test for misplacement) translated into a correctly positioned catheter, whereas a delayed or absent flush (negative RASS or positive screening test) implied a potentially misplaced catheter (Korsten et al., 2018).
After CVC insertion was finished, chest ultrasonography was done by the intensivist to exclude presence of pneumothorax.
- Conditions
- Central Venous Catheter Placement
- Being tested
- ultrasound guided central venous catheter insertion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guided central venous catheter insertionDevice
Prospective comparative randomized controlled clinical study.
| Study group | Role | What they receive |
|---|---|---|
| the standard blind technique for Central venous catheter insertion into the internal jugular vein. | using the blind experience based technique without imaging guidance | |
| ultrasound guided technique for Central venous catheter insertion into the internal jugular vein. | using real time ulrasound guidance Receives: Device: ultrasound guided central venous catheter insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of complications in ultrasound guided central venous catheter insertion
the incidence of complications in ultrasound guided central venous catheter insertion is expected to be lower than the standard blind technique
Measured: 6 months from october 2021 to april 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start20 Oct 2021
- Primary completion30 Mar 2022
- Study completion5 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Venous Catheter PlacementStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ahmed Beniamen Mohamed Hussien, Zagazig University
- Investigators
- ahmed B mohamed, MD, Principal investigator, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05338138
- Sponsor's protocol ID
- ZU-IRB#:6827/30-3-2021
- Status last verified
- Apr 2022
- First submitted
- 8 Apr 2022
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: protocol only
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point of Care Ultrasonography Versus Standard Blind Technique for Central Venous Catheter Insertion in Emergency Hospital
- ClinicalTrials.gov ID
- NCT05338138
- Acronym / sponsor ID
- ZU-IRB#:6827/30-3-2021
- Conditions
- Central Venous Catheter Placement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 5 Apr 2022 (actual)
- First posted
- 21 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A lot of complications occur during central venous catheter insertion in intensive care units all over the world most commonly pneumothorax, misplacement and infection. So in this study we will assess the effect of using ultrasonography guidance for CVC insertion to reduce incidence of complications and to confirm placement compared to standard blind technique.
Detailed description
Central venous catheter (CVC) - also called central venous access, central venous line, or central line - is a thin catheter that is inserted through one of the large veins in the neck area into the venous system. It ends in one of the venae cavae just before entering the right atrium.
CVC is a procedure frequently required in critical care units. Indications include patients with multiple, incompatible intravenous (IV) medications with limited peripheral access, or who are being treated with vasoactive or phlebosclerotic agents which may not be suitably cared for with a peripheral IV alone. Some central lines are also placed for temporary or permanent hemodialysis access; these dialysis catheters are significantly larger than traditional double, triple, or quadruple lumen catheters placed in the emergency department or intensive care unit setting.
Central lines are placed today via the Seldinger technique, in which the chosen vein is cannulated with a needle, a guidewire is inserted to maintain a tract through the skin into the vein, and the catheter is then inserted over the wire into the vein before the wire is removed. When this procedure was performed blindly it was called the standard technique, while if it was done with ultrasound guidance it is called ultrasound guided technique.
Patients were selected from emergency hospital at zagazig university hospitals who needed CVC insertion as an important part of management plan
All Cases underwent:
- Patient Examination: regarding written consent from patients or relatives when possible, site of planned insertion, explanation to the patient if conscious and cooperative and checking platelet count and INR if available (not necessary in emergency situation)
- Randomization: A computer-generated randomization table allocated the patients into 2 equal groups.
- Preparation: Once the site was chosen, a topical antiseptic such as chlorhexidine or betadine was applied circularly to the skin in ever-enlarging circles. Once applied, the antiseptic was allowed to dry to maximize the decrease in skin surface bacterial cell count. After securing the line in vivo, it was also common practice to flush the central line with sterile saline to prevent clotting within the catheter, as well as to confirm the functionality of all ports. This step was performed both prior to insertion and after insertion of the catheter.
- Personnel: When possible, having an assistant present during the procedure was helpful.
- Equipment for CVC insertion:
- Central line insertion kit, which is usually manufacturer-specific should contain the all the equipment for the central line and Seldinger technique, including a central venous catheter, guidewire, syringe, an introducer needle, a scalpel, a silk suture (on a Keith or curved needle) and a skin dilator
- Sterile gloves and gown
- Hat and mask
- Drape or sterile towels to create a sterile barrier (to protect equipment and materials from becoming contaminated)
- Antiseptic agent for skin preparation
- Proper caps for each lumen port
- Dressing to cover the insertion site
- Local anesthetic (1% to 2% lidocaine)
- If an ultrasound-guided technique was used, a sterile probe cover was used.
- Technique:
In group A: the insertion site was anesthetized by injecting local anesthetic sufficient to create a wheal under the skin. then the needle was advanced towards the venous target, aspirating then injecting anesthetic into the subcutaneous tissue. Once the area is anesthetized, the introducer needle was introduced into the skin, and advanced toward the vein being cannulated, all the while aspirating with steady pressure. then continued as seldinger maneuver In group B: the ultrasound machine was employed using the linear probe, the probe was covered by a sterile cover, and then localization of internal jugular vein (IJV) was done. The IJV was adjusted to be at the center of the ultrasound monitor view then slight compression on IJV was done to ensure its patency and collapsibility and to differentiate IJV from carotid artery that should be visualized beside or behind the IJV as a pulsating non collapsible vessel that colors red on Doppler while the IJV colors blue on Doppler. then the next steps were continued as the standard blind technique. Immediately after CVC placement, a saline flush consisting of 10 mL of normal saline was injected into the distal hub of the CVC by the interventionist while focused echocardiography was conducted by a second resident. The time required for the procedure was recorded. Appearance of an opacification of the right atrium (RASS) was judged as "immediate" (less than two seconds after injection), "delayed" (appearing more than two seconds after injection) or "absent". Echocardiography was immediately evaluated by the resident placing the catheter and the result ("delayed", "immediate" or "absent" flush) recorded by one investigator (EM). The examination was repeated up to three times and catheter position corrected during placement when the saline flush test was indicative of a problem. Overall, a positive RASS (negative screening test for misplacement) translated into a correctly positioned catheter, whereas a delayed or absent flush (negative RASS or positive screening test) implied a potentially misplaced catheter (Korsten et al., 2018).
After CVC insertion was finished, chest ultrasonography was done by the intensivist to exclude presence of pneumothorax.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the standard blind technique for Central venous catheter insertion into the internal jugular vein. | – | –using the blind experience based technique without imaging guidance |
| ultrasound guided technique for Central venous catheter insertion into the internal jugular vein. | – | Device: ultrasound guided central venous catheter insertionusing real time ulrasound guidance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be selected from emergency hospital at zagazig university hospitals who needed CVC insertion as an important part of management plan.
Key inclusion criteria (4 listed)
- Patient acceptance (if conscious)
- Aged >18years.
- Gender: both.
- 5. Patients admitted to emergency hospital units, at emergency room (ER), operation theater (OT) or emergency intensive care unit (ICU)
Key exclusion criteria (6 listed)
- Patient refusal
- Coagulopathy: INR>1.5 or platelet count<500000/cc
- Skin infection at site of insertion
- Physician not well trained on utilization of ultrasound machine or even not familiar with it.
- History of surgical manipulation or trauma at the insertion site
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound guided central venous catheter insertionProspective comparative randomized controlled clinical study. | Device | ultrasound guided technique for Central venous catheter insertion into the internal jugular vein. |
Primary outcome
the incidence of complications in ultrasound guided central venous catheter insertion
Time frame: 6 months from october 2021 to april 2022
the incidence of complications in ultrasound guided central venous catheter insertion is expected to be lower than the standard blind technique
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
- Individual participant dataSharing planned: Undecided. protocol only
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ahmed B mohamed, MD principal investigator
Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Venous Catheter Placement, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of complications in ultrasound guided central venous catheter insertion (time frame: 6 months from october 2021 to april 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2022.